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Proscope™

Dermascope and parts

Class IMDR 2017/745On the marketActive device

Manufacturer: American Diagnostic Corporation
Manufacturer SRN: US-MF-000021544
UDI-DI: 00634782053437
Basic UDI-DI: 0634782000053129J
Reference: 5312
EMDN: Z12040102
EMDN description: EQUIPMENT FOR ANALYSIS OF THE PHYSIOLOGICAL PARAMETERS OF THE SKIN
First on market country: Romania
Authorised representative: S.C. Cattus S.R.L.
Last updated: 16.07.2026 01:06

Manufacturer products Authorised representative products Authorised representative actors View details

AI-Rad Companion Brain MR

MDR_VD_IIa_ERLN_H_127_SAMD_AIRC_MR-B

Class IIaMDR 2017/745No longer on the marketActive device

Manufacturer: Siemens Healthcare GmbH
Manufacturer SRN: DE-MF-000006122
UDI-DI: 04056869968278
Basic UDI-DI: 0405686902008UZ
Reference: 11665399
EMDN: Z12040192
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:38

Manufacturer products View details

AI-Rad Companion (Musculoskeletal)

MDR_VD_IIa_ERLN_H_127_SAMD_AIRC_CT-MSK

Class IIaMDR 2017/745No longer on the marketActive device

Manufacturer: Siemens Healthcare GmbH
Manufacturer SRN: DE-MF-000006122
UDI-DI: 04056869297293
Basic UDI-DI: 0405686902143V8
Reference: 11583325
EMDN: Z12040192
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:38

Manufacturer products View details

AI-Rad Companion (Cardiovascular)

MDR_VD_IIa_ERLN_H_127_SAMD_AIRC_CT-CV

Class IIaMDR 2017/745No longer on the marketActive device

Manufacturer: Siemens Healthcare GmbH
Manufacturer SRN: DE-MF-000006122
UDI-DI: 04056869297286
Basic UDI-DI: 0405686902145VC
Reference: 11583324
EMDN: Z12040192
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:38

Manufacturer products View details

LPV-IC SW 01.xx

1207046XK29Z00

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Drägerwerk AG & Co. KGaA
Manufacturer SRN: DE-MF-000005329
UDI-DI: 04048675803027
Basic UDI-DI: 040486751207046XK29Z000GN
Reference: MS90162
EMDN: Z12040192
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 23:58

Manufacturer products View details

Infinity Converter Service SW 03.xx

307045XK29Z000

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Drägerwerk AG & Co. KGaA
Manufacturer SRN: DE-MF-000005329
UDI-DI: 04048675795766
Basic UDI-DI: 040486751307045XK29Z000HA
Reference: MS90320
EMDN: Z12040192
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 23:57

Manufacturer products View details

Core Software 3.x

307042XK29Z000

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Drägerwerk AG & Co. KGaA
Manufacturer SRN: DE-MF-000005329
UDI-DI: 04048675778110
Basic UDI-DI: 040486751307042XK29Z000F5
Reference: MS90306
EMDN: Z12040192
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 23:57

Manufacturer products View details

ICM-Core 14.0.0

207037XK29Z000

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Drägerwerk AG & Co. KGaA
Manufacturer SRN: DE-MF-000005329
UDI-DI: 04048675749493
Basic UDI-DI: 040486751207037XK29Z000GG
Reference: MK05191
EMDN: Z12040192
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 23:57

Manufacturer products View details

MPW SW 02.xx

307039XK29Z000

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Drägerwerk AG & Co. KGaA
Manufacturer SRN: DE-MF-000005329
UDI-DI: 04048675736158
Basic UDI-DI: 040486751307039XK29Z000K9
Reference: MS90154
EMDN: Z12040192
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 23:57

Manufacturer products View details

Targeted Alarm Service SW 1.n

307043XK29Z000

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Drägerwerk AG & Co. KGaA
Manufacturer SRN: DE-MF-000005329
UDI-DI: 04048675716310
Basic UDI-DI: 040486751307043XK29Z000FU
Reference: MS90129
EMDN: Z12040192
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 23:57

Manufacturer products View details

Connectivity Converter CC300

307040XK19Z000

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Drägerwerk AG & Co. KGaA
Manufacturer SRN: DE-MF-000005329
UDI-DI: 04048675544227
Basic UDI-DI: 040486751307040XK19Z000DA
Reference: MK10101
EMDN: Z12040180
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 23:56

Manufacturer products View details

Omnipod Discover

Class IIaMDR 2017/745On the marketDirect marking

Manufacturer: Insulet Corporation
Manufacturer SRN: US-MF-000007948
UDI-DI: 10385083000152
Basic UDI-DI: 038508DATADV
Reference: PT-001083
EMDN: Z12040182
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Netherlands
Authorised representative: Insulet Netherlands B.V.
Last updated: 15.07.2026 23:48

Manufacturer products Authorised representative products Authorised representative actors View details

Dexcom Flex CGM System

Dexcom Flex Continuous Glucose Monitoring System

Class IIbMDR 2017/745On the marketActive deviceDirect markingMeasuring functionSingle useSterile

Manufacturer: Dexcom
Manufacturer SRN: US-MF-000010694
UDI-DI: 00386270004598
Basic UDI-DI: 038627DEXFLEX67
Reference: STP-DF-001
EMDN: Z1204011585
EMDN description: INVASIVE BLOOD SUGAR MONITORING SYSTEMS, SINGLE–USE SENSORS
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 15.07.2026 23:45

Manufacturer products Authorised representative products Authorised representative actors View details

Dexcom API

Class IMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Dexcom
Manufacturer SRN: US-MF-000010694
UDI-DI: 00386270000668
Basic UDI-DI: 038627APIUC
Reference: SW13183
EMDN: Z1204011599
EMDN description: BLOOD SUGAR MONITORING SYSTEMS - OTHER
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 15.07.2026 23:45

Manufacturer products Authorised representative products Authorised representative actors View details

LifeGlobal Coda Inline Filter: Purple

Class IMDR 2017/745On the marketActive device

Manufacturer: CooperSurgical, Inc.
Manufacturer SRN: US-MF-000002607
UDI-DI: 00888937032901
Basic UDI-DI: 0888937TD004ZB
Reference: CIPR-001-M
EMDN: Z12040180
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: -
Authorised representative: CooperSurgical Distribution B.V.
Last updated: 15.07.2026 22:57

Manufacturer products Authorised representative products Authorised representative actors View details

LifeGlobal Coda Xtra Inline Filter: Green

Class IMDR 2017/745On the marketActive device

Manufacturer: CooperSurgical, Inc.
Manufacturer SRN: US-MF-000002607
UDI-DI: 00888937032918
Basic UDI-DI: 0888937TD004ZB
Reference: CXGR-001-M
EMDN: Z12040180
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: -
Authorised representative: CooperSurgical Distribution B.V.
Last updated: 15.07.2026 22:57

Manufacturer products Authorised representative products Authorised representative actors View details

ORIGIO® Gas Line Filter

Class IMDR 2017/745On the marketActive device

Manufacturer: CooperSurgical, Inc.
Manufacturer SRN: US-MF-000002607
UDI-DI: 00888937033915
Basic UDI-DI: 0888937TD004ZB
Reference: ULTRA-001-M
EMDN: Z12040180
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: -
Authorised representative: CooperSurgical Distribution B.V.
Last updated: 15.07.2026 22:57

Manufacturer products Authorised representative products Authorised representative actors View details

LifeGlobal Coda 2 Incubator Unit

Class IMDR 2017/745On the marketActive device

Manufacturer: CooperSurgical, Inc.
Manufacturer SRN: US-MF-000002607
UDI-DI: 00888937032871
Basic UDI-DI: 0888937TD004ZB
Reference: C2IU-010-M
EMDN: Z12040180
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: -
Authorised representative: CooperSurgical Distribution B.V.
Last updated: 15.07.2026 22:57

Manufacturer products Authorised representative products Authorised representative actors View details

LifeGlobal Coda Filter for Incubator Unit

Class IMDR 2017/745On the marketActive device

Manufacturer: CooperSurgical, Inc.
Manufacturer SRN: US-MF-000002607
UDI-DI: 00888937032840
Basic UDI-DI: 0888937TD004ZB
Reference: GCIF-001-M
EMDN: Z12040180
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: -
Authorised representative: CooperSurgical Distribution B.V.
Last updated: 15.07.2026 22:57

Manufacturer products Authorised representative products Authorised representative actors View details

VEOS

51550

Class IMDR 2017/745On the marketActive device

Manufacturer: CANFIELD SCIENTIFIC Inc
Manufacturer SRN: US-MF-000042029
UDI-DI: 00860010618134
Basic UDI-DI: 008600106181VEOS8K
Reference: 51550
EMDN: Z12040108
EMDN description: DERMATOSCOPES
First on market country: Italy
Authorised representative: CANFIELD SCIENTIFIC SRL
Last updated: 15.07.2026 22:39

Manufacturer products Authorised representative products Authorised representative actors View details